Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)

October 8, 2019 updated by: Qi Qian, M.D., Mayo Clinic
Nephrology participation in care of patients undergoing CABG could reduce AKI through correction of modifiable risk factors and early detection and intervention of post-op AKI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (Age >18 years)
  • Elective CABG at Mayo Clinic Rochester and Shanghai Zhongshan Hospital from 7/1/2016 to 6/30/2017

Exclusion Criteria:

  • Non-elective CABG
  • Renal failure on dialysis
  • Renal transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
If participants are randomized into the non-intervention group, the participants' information during the study period will be collected. Participants will be managed by a care provider as per the standard of care. Participants may receive nephrology consultation as indicated clinically.
Experimental: Standard of Care plus Nephrology Care
If participants are randomized into the intervention group, participants' information will be checked by the study investigators daily for 7 days (2 days pre-op and 5 days post-op). When appropriate, investigators may give suggestions to minimize the participants' risk(s) for AKI. Participant's primary care providers may take the suggestions into consideration. Participants' primary care providers are not obligated to carry out the suggestions that are given.
Procedure: Standard of Care plus Nephrology Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perfusion pressures (mean arterial pressure) ≥ 65-70 mmHg
Time Frame: baseline to 5 days
baseline to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Qi Qian, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

June 10, 2019

Study Completion (Actual)

June 10, 2019

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-003845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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